Cleared Traditional

K771612 - WELL TYPE GAMMA COUNTER

K771612 is an FDA 510(k) clearance for WELL TYPE GAMMA COUNTER, manufactured by Actus, Inc.. The device is a Class 1 Radiology device with product code JJJ cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K771612 · Actus, Inc. · Radiology device
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Apr 1978
Decision
230d
Days
Class 1
Risk

K771612 is an FDA 510(k) clearance for the WELL TYPE GAMMA COUNTER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Actus, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1978 after a review of 230 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 862.2320 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Actus, Inc. devices

FDA 510(k) Submission Details - K771612

510(k) Number K771612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1977
Decision Date April 10, 1978
Days to Decision 230 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 107d · This submission: 230d
Pathway characteristics
Predicate-based equivalence.

JJJ Device Classification - Class 1, General Controls

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJJ Counter (beta, Gamma) For Clinical Use

All 33
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K771612.
NUCLEAR SAMPLE READER
K790905 · Abbott Laboratories · Jun 1979
SCINTILLATION, LIQUID, RACKBETA
K780341 · Lkb Instruments, Inc. · May 1978
GAMMA COUNTER
K780344 · Lkb Instruments, Inc. · Apr 1978
COUNTER, RADIOASSAY, AUTO., MICROMEDIC
K780383 · Micromedic Systems · Mar 1978
PRINTER
K772099 · Miles Laboratories, Inc. · Jan 1978
LIQ. SCINTILLATION SPECTROPHOTOMETEO
K771369 · Beckman Instruments, Inc. · Sep 1977